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临床试验/NCT01423734
NCT01423734已完成不适用

Pilot Study To Assess The Reproducibility Of Diffusion Weighted Magnetic Resonance Imaging For Neuroendocrine Tumor Liver Metastases

Memorial Sloan Kettering Cancer Center1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
reproducibility of diffusion weighted imaging for neuroendocrine liver metastases.

研究概览

简要总结

Imaging with CT (Computed Tomography) or MRI (Magnetic Resonance Imaging) is normally used to see how tumors respond to treatment. If tumors shrink after therapy, doctors continue with the same treatment. On the other hand, growing tumors in a patient can bring about a change in therapy. Unfortunately, it often takes three to six months, or even longer before the investigators see tumors shrink or grow on scans. Doctors are looking for new imaging tools that can look at how tumors respond early on during treatment. This study will help us decide if such an MRI technology called DWI (Diffusion Weighted Imaging) can be used as a helpful imaging tool.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histopathologic evidence of well differentiated neuroendocrine tumor of gastroenteropancreatic origin
  • Evidence of metastatic disease of at least 2.0 cm in the liver by MRI or CT imaging.
  • Patient ≥18 years of age on the day of signing informed consent.

排除标准

  • Any contraindication to MRI based on departmental MR questionnaire
  • Inability to cooperate for an MR exam
  • Patient has a history of a second active malignancy with evidence of metastases. Patients with a history of resected prior malignancy or one that would not interfere with the MRI results is allowed.
  • Patient has known psychiatric or substance abuse disorders that would, in the opinion of the treating investigator, interfere with cooperation with the requirements of the trial.

结局指标

主要结局

reproducibility of diffusion weighted imaging for neuroendocrine liver metastases.

时间窗: 2 years

The investigators will calculate an ADC value for each metastasis that was chosen through consensus by the two participating radiologists. ADC is a voxel-level measurement so summary measures will be employed in order to get a single measurement for the ROI of each metastasis under study. For both the clinical and research MRI, the investigators will take the voxel-level data and calculate the mean, median, and minimum ADC within each ROI.

次要结局

  • evaluate the reproducibility perfusion insensitive diffusion coefficients (ADC high) of liver metastases(2 years)
  • evaluate the repeatability of perfusion insensitive diffusion coefficients ADC high of liver metastases(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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